Not Yet Recruiting PHASE3 INTERVENTIONAL 3-arm NCT07296445

A Trial to Investigate Whether Oral Arsenic Trioxide Is Similar to Intravenous Arsenic Trioxide in Pharmacokinetics, Safety, and Efficacy (LATITUDE/SDKARS-301) (LATITUDE)

LATITUDE - A Phase 3, Randomized, Open-Label, 3-Cohort, 2-Period, 2-Sequence, Crossover Trial to Evaluate the Pharmacokinetics, Safety, and Efficacy of Oral Arsenic Trioxide Versus Intravenous Arsenic Trioxide for Consolidation Therapy in Participants With Newly Diagnosed, Non-High-Risk, Acute Promyelocytic Leukemia

Sponsor: SDK Therapeutics, Inc.

Conditions APL Acute Promyelocytic Leukaemia Acute Promyelocytic Leukemia Acute Promyelocytic Leukemia (APL) Acute Promyelocytic Leukemia With PML-RARA Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA Leukaemia Leukemia Acute Promyelocytic Leukemia (APL) Leukemia, Acute

Interventions IV Arsenic Trioxide Oral ATO all-trans retinoic acid (ATRA)

Updated 1 time since 2026 Last updated: Dec 25, 2025 Started: Jan 31, 2026 Primary completion: Jun 30, 2027 Completion: Jan 31, 2029

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on APL and Acute Promyelocytic Leukaemia, this trial is actively recruiting participants. The trial is conducted by SDK Therapeutics, Inc. and has accumulated 1 data snapshot since 2026. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

Change History

1 version recorded

Not Yet Recruiting — PHASE3 [monthly]

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

SDK Therapeutics, Inc.

Data source: SDK Therapeutics, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.